Glycemic Index and Brain Function

NCT01064778 | Completed

• 1 other identifier: RA-003
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

Brief Summary

The investigators propose examine the effects of the dietary factor glycemic index (GI) on brain areas that control food intake and hunger. This knowledge could help design dietary approaches that decrease hunger, and thus promote new weight loss strategies.

Conditions

Obesity

Keywords

Glycemic Index; Brain; Intake Regulation; Weight Loss; Hunger; Diet

Outcome Measures

Primary Outcomes (1)

• Blood Flow in Brain Areas of Intake Control.

  4 hours postprandial

Secondary Outcomes (7)

• Subjective Hunger Rating

  Every 30 minutes for 5 hours.

• Blood Glucose Level

  Every 30 minutes for 5 hours.

• Blood Insulin Level

  Every 30 minutes for 5 hours

• Blood Glucagon Level

  Every 30 minutes for 5 hours.

• Blood Growth Hormone Level

  Every 30 minutes for 5 hours.

Study Arms (2)

Low GI

ACTIVE COMPARATOR

Other: Low GI

High GI

EXPERIMENTAL

Other: High GI

Interventions

Low GI OTHER

Subjects will be instructed to consume a liquid test meal with a low GI over 5 minutes after baseline laboratory evaluations. The low and high GI meal contain similar amounts of milk, oil, dried egg whites, equal, and vanilla extract. The low GI meal corn-starch as a carbohydrate. Both meals have similar macronutrient composition (60% carbohydrate, 15% protein, 25% fat), micronutrient profiles, physical properties, palatability and sweetness. The high vs. low GI meals have a predicted difference in GI of 90 vs. 40, and consistent with this prediction, a pilot study in obese young adults found a 2.2-fold difference in glycemic response (p\<0.001). The test meals will provide 25% of individual daily energy requirements.

Low GI

High GI OTHER

Subjects will be instructed to consume a liquid test meal with a high GI over 5 minutes after baseline laboratory evaluations. The low and high GI meal contain similar amounts of milk, oil, dried egg whites, equal, and vanilla extract. The high GI meal contains corn-syrup as a carbohydrate. Both meals have similar macronutrient composition (60% carbohydrate, 15% protein, 25% fat), micronutrient profiles, physical properties, palatability and sweetness. The high vs. low GI meals have a predicted difference in GI of 90 vs. 40, and consistent with this prediction, a pilot study in obese young adults found a 2.2-fold difference in glycemic response (p\<0.001). The test meals will provide 25% of individual daily energy requirements.

High GI

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males age 18 to 35 years
• BMI less than or equal to 25 for age and gender

You may not qualify if:

• weight \> 300 lbs
• largest body circumference \> 144cm
• body shape incompatible with MRI scanner or equipment
• large fluctuations in body weight (5% over preceding 6 months, 2.5% during the study)
• known medical problems that may affect metabolism or hormones
• diabetes mellitus (fasting plasma glucose ≥126 mg/dL)
• other abnormal laboratory screening tests
• taking any medications or dietary supplements that might affect body weight, appetite, or energy expenditure
• smoking or illicit substance abuse
• high levels of physical activity (\>30 minutes per day, \> 4days per week)
• currently following a weight loss diet
• allergies or intolerance to eggs, vanilla extract, equal, canola oil, milk, cornstarch, corn syrup

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Boston Children's Hospital: collaborator
• Brigham and Women's Hospital: collaborator

Study Sites (3)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• Lennerz BS, Alsop DC, Holsen LM, Stern E, Rojas R, Ebbeling CB, Goldstein JM, Ludwig DS. Effects of dietary glycemic index on brain regions related to reward and craving in men. Am J Clin Nutr. 2013 Sep;98(3):641-7. doi: 10.3945/ajcn.113.064113. Epub 2013 Jun 26.

  PMID: 23803881 DERIVED

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• David S Ludwig, MD, PhD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

• David Alsop, PhD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

• Belinda S Lennerz, MD, PhD

  Boston Children's Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of MRI Research

Study Record Dates

• First Submitted: February 5, 2010
• First Posted: February 8, 2010
• Study Start: February 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: September 1, 2011
• Last Updated: February 2, 2012

Record last verified: 2012-02

Locations

US (3)